Hybrid Global Regulatory Affairs Associate Director – Cardio-Metabolic

Posted last week

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About the role

  • Lead the implementation of regulatory strategies and operational activities across major global regions.
  • Provide strategic input into global regulatory plans, identifying risks and contributing to key planning documents.
  • Align regional regulatory approaches with global objectives through collaboration with cross-functional and regional teams.
  • Define and manage Health Authority (HA) interaction strategies, including preparation of briefing materials.
  • Oversee the planning, coordination, and submission of regulatory dossiers (e.g., CTAs, INDs, Risk Management Plans).
  • Serve as a liaison with local HAs (e.g., FDA, EMA) and lead or support negotiations for regional approvals.
  • Develop and implement strategies to minimize review delays and regulatory clock stops.
  • Ensure timely and compliant responses to HA queries and requests.
  • Contribute to departmental goal setting and lead initiatives to improve regulatory processes.
  • Ensure adherence to internal policies, SOPs, and global regulatory requirements.

Requirements

  • Bachelor’s or Master’s degree in Life Sciences, Pharmacy, or a related field.
  • Significant experience in regulatory affairs within the pharmaceutical industry.
  • Proven track record in project management and regulatory operations.
  • Experience representing the organization in cross-functional and cross-cultural settings.
  • Strong knowledge of clinical trials, drug development, and regulatory compliance.
  • Excellent problem-solving, negotiation, and communication skills.
  • Detail-oriented with the ability to manage complex regulatory projects.
  • Skilled in risk management and working with cross-functional teams.
  • Ability to navigate and influence Health Authority interactions.
  • Fluency in English (written and spoken) is essential.

Benefits

  • Hybrid (12 days per month on-site if living within 50 miles to our London office)
  • Remote (if living beyond 50 miles to our London office)

Job title

Global Regulatory Affairs Associate Director – Cardio-Metabolic

Job type

Experience level

Senior

Salary

Not specified

Degree requirement

Bachelor's Degree

Location requirements

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